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VELSIPITY Drug Patent Profile

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When do Velsipity patents expire, and when can generic versions of Velsipity launch?

Velsipity is a drug marketed by Pfizer and is included in one NDA. There are seven patents protecting this drug.

This drug has ninety-eight patent family members in twenty-seven countries.

The generic ingredient in VELSIPITY is etrasimod arginine. Two suppliers are listed for this compound. Additional details are available on the etrasimod arginine profile page.

DrugPatentWatch^® Generic Entry Outlook for Velsipity

Velsipity will be eligible for patent challenges on October 12, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 12, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VELSIPITY

International Patents:	98
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for VELSIPITY
What excipients (inactive ingredients) are in VELSIPITY?	VELSIPITY excipients list
DailyMed Link:	VELSIPITY at DailyMed

Drug patent expirations by year for VELSIPITY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VELSIPITY

Generic Entry Date for VELSIPITY^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 216956 Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VELSIPITY

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

US Patents and Regulatory Information for VELSIPITY

VELSIPITY is protected by seven US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VELSIPITY is ⤷ Sign Up.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VELSIPITY

Crystalline L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta [b]indol-3-yl)acetic acid(Compund1) for use in SIPI receptor-associated disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Crystalline L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta [b]indol-3-yl)acetic acid(Compound 1) for use in SIPI receptor-associated disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR TREATING ULCERATIVE COLITIS BY ADMINISTERING A THERAPEUTICALLY EFFECTIVE AMOUNT OF THE FORM OF ESTRASIMOD ARGININE AS CLAIMED

Methods of treating conditions related to the S1Preceptor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR TREATING ULCERATIVE COLITIS BY ADMINISTERING ESTRASIMOD ARGININE IN AN AMOUNT EQUIVALENT TO ABOUT 2.0 MG OF ESTRASIMOD

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR TREATING ULCERATIVE COLITIS BY ADMINISTERING A THERAPEUTICALLY EFFECTIVE AMOUNT OF THE FORM OF ESTRASIMOD ARGININE AS CLAIMED

Substituted 1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid derivatives useful in the treatment of autoimmune and inflammatory disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR TREATING ULCERATIVE COLITIS BY ADMINISTERING A THERAPEUTICALLY EFFECTIVE AMOUNT OF ESTRASIMOD ARGININE

FDA Regulatory Exclusivity protecting VELSIPITY

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for VELSIPITY

See the table below for patents covering VELSIPITY around the world.

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1253714	用於S1P1受體相關病症的(R)-2-(7-(4-環戊基-3-(三氟甲基)苄基氧基)-1，2，3，4-四氫環戊並[B]吲哚-3-基)乙酸(化合物1)的結晶L-精氨酸鹽 (CRYSTALLINE L-ARGININE SALT OF (R)-2-(7-(4-CYCLOPENTYL-3-(TRIFLUOROMETHYL)BENZYLOXY)-1,2,3,4-TETRAHYDROCYCLO-PENTA[B]INDOL-3-YL)ACETIC ACID(COMPOUND1) FOR USE IN SIPI RECEPTOR-ASSOCIATED DISORDERS)	⤷ Sign Up
Japan	2016029067	自己免疫障害および炎症性障害の処置において有用な置換型１，２，３，４−テトラヒドロシクロペンタ［ｂ］インドル−３−イル）酢酸誘導体 (SUBSTITUTED 1,2,3,4-TETRAHYDROCYCLOPENTA[B]INDOL-3-YL)ACETIC ACID DERIVATIVES USEFUL IN TREATMENT OF AUTOIMMUNE AND INFLAMMATORY DISORDERS)	⤷ Sign Up
Hungary	E030424		⤷ Sign Up
Australia	2022283660	Methods of treating conditions related to the S1P1 receptor	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration